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U.S. Department of Health and Human Services

Class 2 Device Recall CORPUS II

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  Class 2 Device Recall CORPUS II see related information
Date Initiated by Firm September 01, 2017
Date Posted October 03, 2017
Recall Status1 Terminated 3 on May 04, 2021
Recall Number Z-0006-2018
Recall Event ID 78079
510(K)Number K041219  K071650  K991658  
Product Classification Wheelchair, powered - Product Code ITI
Product Electric Wheelchair bases:
a) C300
b) C350
c) C400
d) C500
Code Information a) C300, Serial Numbers: DOMESTIC: 43506329 43702293 43702295 2597000093 2597000105 2597000120  INTERNATIONAL: 43507565 43507903 43507955 43508148 43601189 43703638 43704109 43704250 43704286 43704299 43704314 43704322 43704323 43704324 43704405 460001307 461000015 461000016 461000034 461000040 461000051 461000061 461000080 461000088 461000105 461000106 461000107 461000108 461000109 461000156 461000165 461000191 461000192 461000196 461000202 461000231   b) C350, Serial Numbers: INTERNATIONAL (ONLY) 43101851 43101909 43101947 43101970 43102014 43102015 43102019 43102048 43102052 43204766  c) C400, Serial Numbers: INTERNATIONAL (ONLY) 44504301 44504476 44504523 44504595 44504713 44504785 44504871 44504887 44504915 44504926 44504985 44505112 44505113 44505285 44505443 44505565 44505622 44505729 44505739 44505767 44505985 44506199 44506290 44506338 44506373 44506544 44506602 44506617 44507101 44507119  d) C500, Serial Numbers: DOMESTIC: 2555000951  INTERNATIONAL: 15004546 15503636 15503640 15503687 15503688 15503691 15503731 15503732 15503733 15503746 15503747 15503748 15503749 15702097 15702755 15702772 15702774 15702775 15702776 15702777 15702790 15702791 15702792 15702793 15702796 15702798 15702799 15702800 15702801 15702802 45501186 45501198 45501202 45501269 45501312 45501326 45501416 45501424 45501497 45501506 45501509 45501604 45501683 45501714 45501736 45501753 45501989 45502028 45502151 45502283 45502340 45502342 45700476 45700712 45700771 45701602 45702143 45703007 45703392 45703559 45703608 45703631 459000050 
Recalling Firm/
Manufacturer		 Permobil, Ab
Arvaltsvagen 10
Box 120
Timra Sweden
Manufacturer Reason
for Recall		 There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.
FDA Determined
Cause 2		 Device Design
Action The firm initiated the recall by letter on 09/01/2017. The distributor/dealers were instructed as follows: LOG INTO CORRECTION WEB PORTAL Immediately log into www.permobilfsa.com. Log in with the following ID and Password. CEASE DISTRIBUTION OF EXISTING INVENTORY Please examine your inventory for the serial numbers assigned to you, cease distribution, and quarantine those chairs. IMMEDIATELY PERFORM INSPECTION If you have distributed these serial numbers to end users, you must immediately contact them to perform a visual inspection of the top plate assembly looking for obvious signs of cracking. If the top plate shows no signs of cracking the wheelchair may continue to be used in accordance with the owners manual until the correction is performed. If the top plate does show signs of cracking please inform the user that the chair cannot be used until the correction is performed. Next, log into the web portal to obtain further instructions and assistance. In these cases which are expected to be rare, we will assist with a temporary solution to keep the client mobile during the time between inspection and correction. PERFORMING THE CORRECTION You will be notified when repair kits are available and the process to follow to obtain the proper kit for the serial number you are correcting. The web portal will include a template letter to send to end users explaining the hazard and the need to cooperate with this correction effort. Correction instructions and related supporting materials will also be available. We are also providing the end user with a certificate for a free light kit towards the purchase of a new Permobil power chair. Please contact your Permobil sales representative if you have any questions regarding this correction.
Quantity in Commerce 146 units
Distribution Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = PERMOBIL A.B.
510(K)s with Product Code = ITI and Original Applicant = PERMOBIL AB
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